BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS

    FDA 510(k)
    FDA Class 1 ·Neurology

    MATERIAL TOOTHSADE RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    WALRUS EXTENSION SET SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code FPA·June 11, 2010

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·December 21, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 19, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024